Events

Recall of SERVO-I VENTILATOR SYSTEM - CO2 ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28726
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The affected co2 analyzer modules may experience a problem at the end of the calibration of the capnostat 3 sensor causing the calibration to fail and activate the medium priority alarm "co2 module error" on the user interface of the servo ventilator. this issue only affects the optional co2 analyzer functionality preventing it from displaying any measured co2 values.It has no effect on any other functionality of the ventilator.

Device

SERVO-I VENTILATOR SYSTEM - CO2 ANALYZER
  • Model / Serial
    Model Catalog: 65 23 588 E407E (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    SERVO-I VENTILATOR SYSTEM - CO2 ANALYZER
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC